Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets

NCT ID: NCT05168683

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2022-02-23

Brief Summary

The purpose of the study is to understand the gastrointestinal transit time and disintegration behavior of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal or in fasted or other fed states.

Detailed Description

This study includes two parts. Part One will evaluate two ALLN-346 formulations, a fast release and a slower sustained release. Subjects will receive a single tablet of each formulation and a capsule of each formulation at separate assessment visits. Subjects will attend a maximum of 4 assessment visits. The primary purpose of this part of the study is to understand the gastrointestinal transit time and disintegration behaviour of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal.

Part Two will involve a second cohort of subjects and will comprise further scintigraphic studies on one or both formulation(s) from Part One in fasted and/or fed states. Subjects will attend a maximum of 4 assessment visits, the number of treatment arms will be decided following completion of Part One.

Conditions

Hyperuricemia; Gout

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part One

Four Study Treatments will be dosed during Part One of the study with radiolabelled ALLN-346 tablets (in 12 subjects): Treatment A ALLN-346 enteric coated (EC) fast release tablet; Treatment B ALLN-346 fast release capsule; Treatment C ALLN-346 EC slow release tablet; Treatment D ALLN-346 slow release capsule. Subjects will be dosed in a lightly fed state.

Group Type: EXPERIMENTAL

Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal

Intervention Type: DRUG

Dosing or radiolabelled ALLN-346 fast or slow release tablets or capsules. Scintigraphic images will be taken

Part Two

Following completion of Part One of the study, study treatment (one or both of those administered in Part One) and dosing requirements will be confirmed for dosing in Part Two, to be administered in fasted and/or fed states (in 12 subjects).

Group Type: EXPERIMENTAL

Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state

Intervention Type: DRUG

Selected dosing of Part One treatments in fasted and/or fed states

Interventions

Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal

Dosing or radiolabelled ALLN-346 fast or slow release tablets or capsules. Scintigraphic images will be taken

Intervention Type: DRUG

Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state

Selected dosing of Part One treatments in fasted and/or fed states

Intervention Type: DRUG

Other Intervention Names

Engineered urate oxidase radiolabelled; Engineered urate oxidase radiolabelled

Eligibility Criteria

Inclusion Criteria

• BMI between 18 and 30 kg/m², inclusive.
• Body weight ≥50 kg
• Voluntary written informed consent
• Good general health with no clinically significant and/or relevant abnormalities of medical history or prior to dosing evaluations, including physical examination, vital signs and ECG and screening clinical laboratory results

Exclusion Criteria

• Current or recurrent disease that could affect the study conduct or laboratory assessments
• History of current or relevant previous non-self-limiting gastrointestinal disorders
• Currently suffering from disease known to impact gastric emptying, e.g., migraine, Type 1 or Type 2 diabetes mellitus
• Untreated hypertension or has hypertension under treatment.
• Diagnosis of an immunosuppressive illness or a condition requiring chronic immunosuppression.
• As a result of a physical examination or screening investigations, and available prior to dosing evaluations, the PMI or medically qualified designee/physician responsible considers the volunteer unfit for the study
• Any contradictions to the gamma scintigraphy procedure
• Measured body temperature >38°C at screening visit (COVID-19 risk reduction procedure)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

BDD Pharma Ltd

INDUSTRY

Sponsor Role: collaborator

Allena Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Tosone

Role: STUDY_DIRECTOR

Allena Pharmaceuticals, Inc.

Locations

BDD Pharma Ltd Bio-Imaging Centre Within Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom

Countries

United Kingdom

Other Identifiers

ALLN-346-103

Identifier Type: -

Identifier Source: org_study_id